Perform data management and analysis activities including the documentation and maintenance of appropriate confidentiality and security of files for the study and sub-studies; lead the development of the protocol and manuals of procedures development; continue to support a morbidity/ mortality monitoring and adjudication system; maintain quality control and monitoring of the performance status of the Regional Centers; maintain the biological specimen laboratory; solicit and monitor laboratories; coordinate, arrange,participate in, and provide any information necessary for regular Steering Committee, Observations Study Monitoring Board, training and other necessary study meetings; and provide technical reports as required by the Government.